Status:
COMPLETED
Investigation of a Novel Positive Pressure Therapy to Rescue Patients Failing to Tolerate CPAP During an Initial Encounter
Lead Sponsor:
Clayton Sleep Insititute
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
21-75 years
Phase:
PHASE3
Brief Summary
The primary objective outcome is the proportion of participants compliant (at least four hours of use per night for all nights) in the Auto Bilevel group compared to the CPAP group after 90 days of tr...
Detailed Description
The hypothesis of this investigation is that the BiPAP® Auto with Bi-Flex® improves acceptance of and adherence to positive pressure therapy in participants who are newly diagnosed with OSA and who me...
Eligibility Criteria
Inclusion
- Inclusion Criterion:
- Age 21-75
- New Diagnosis of OSA with a baseline RDI ≥ 15 events/hr of sleep determined by either full night or split night PSG
- Able and willing to provide written informed consent
- Able to follow study procedures
- Sub-optimal PSG titration with at least 3 hours of attempted PAP titration (defined below): and deemed by their physician as a titration failure
- Sub-optimal PSG titration: at least one of the following:
- Poor sleep efficiency during titration period (sleep efficiency ≤ 70%) (participants may be on sleep medications as per standard lab CPAP protocol ) or;
- Frequent arousals based on three seconds of alpha frequency on EEG (non PLM-related) of 20 or greater per hour during the titration portion of the study or;
- CPAP titration aborted due to participant's request (due to intolerance), or
- Persistent sleep disruption despite therapeutic CPAP therapy and in the judgment of the reviewing physician, suggesting a low probability to CPAP adherence
- Exclusion Criterion:
- Participation in another interventional research study within the last 30 days
- Major uncontrolled medical or psychiatric condition such as congestive heart failure, neuromuscular disease, renal failure etc.
- Prior CPAP or Bi-Level PAP use (within last 2 years)
- Chronic respiratory failure or insufficiency, moderate COPD (FEV1 \< 60%), or any known condition of an elevation of arterial carbon dioxide levels while awake
- Surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days
- Presence of an untreated, diagnosable, non-OSA related sleep disorder (e.g. restless legs syndrome, insomnia, etc.)
- Periodic Limb movement arousal index of 10 or greater.
- Refusal to consider further interventions to standard CPAP to optimize positive pressure therapy (e.g. different mask than what was used in lab)
- PAP therapy otherwise medically complicated or contraindicated such as those with a difficult to size or adjust interface (mask) resulting in facial pain, skin irritation or trauma, or excessive air leaks
- Shift workers or people experiencing jet lag
- Known history of alcohol and or drug abuse
- Diagnosis of Complex Sleep Apnea, (appears to be classic obstructive or mixed sleep apnea, but exhibits disruptive central apneas and periodic breathing on CPAP) 11, 12 or persistent central apnea during diagnostic PSG.
- Diagnosis of Attention Deficit Hyperactivity Disorder
- Chronic Hypnotic use (nightly use for three months or less)
Exclusion
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00635206
Start Date
September 1 2007
End Date
May 1 2009
Last Update
July 14 2009
Active Locations (1)
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1
Clayton Slep Institute
St Louis, Missouri, United States, 63143